FDA.reportPublic FDA data

Mpact Acetabular System

Primary DI
07630040730280
Brand
Mpact Acetabular System
Company
Medacta International SA
Model
01.32.2248HC10A
Device description
Face-changing 10° PE HC liner Ø22/F
Published
2019-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183582000MPACT ExtensionMedacta International S.A.2019-03-21LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630040730280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630040730280076300407302807630040730280

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630345700551NextAR TSA Platform5.3KSWNXAR2026-07-10
07630542776755Surgical Manual Instrument01.10.10.20922026-07-07
07630542778285Surgical Manual Instrument01.10.10.20932026-07-07
07630542778292Surgical Manual Instrument01.10.10.20942026-07-07
07630542791659Surgical Manual Instrument03.51.10.07412026-07-07
07630542788314AMIStem-P13.000092026-06-08
07630542788321AMIStem-P13.000102026-06-08
07630542788338AMIStem-P13.000112026-06-08
07630542788345AMIStem-P13.000122026-06-08
07630542788352AMIStem-P13.000132026-06-08
07630542788369AMIStem-P13.000142026-06-08
07630542788376AMIStem-P13.000152026-06-08
07630971243637AMIStem-P Short Neck01.18.4592020-01-29
07630971243644AMIStem-P Short Neck01.18.4602020-01-29
07630971243651AMIStem-P Short Neck01.18.4612020-01-29
07630971243668AMIStem-P Short Neck01.18.4622020-01-29
07630971243675AMIStem-P Short Neck01.18.4632020-01-29
07630971243682AMIStem-P Short Neck01.18.4642020-01-29
07630971243699AMIStem-P Short Neck01.18.4652020-01-29
07630971243705AMIStem-P Short Neck01.18.4662020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448784MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448791MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448807MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448814MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448821MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448838MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448845MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448852MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448869MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448876MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448883MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448890MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
00810068850079Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850086Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850093Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850109Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850116Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850123Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850130Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850147Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850154Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850185Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850192Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850208Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850215Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26
00810068850222Biocore9 Acetabular Cup SystemBiocore9, LLCLPH2026-06-26